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临床试验/NCT06636630
NCT06636630已完成不适用

Evaluating the Efficacy of Double Flap Versus Quadruple Flap Techniques in Stabilizing Ball Implants Post-Evisceration: a Comparative Analysis

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Evaluating the post-operative extrusion rates of the ball implant from the scleral shell

研究概览

简要总结

The primary objective of this interventional study is to compare the efficacy and outcomes of the double flap and quadruple flap closure techniques in securing ball implants after evisceration. Specific objectives include:

  1. Assessing the rate of implant migration and extrusion.
  2. Evaluating the long-term stability of the implant within the scleral shell.
  3. Investigating the occurrence of complications such as exposure or infection.
  4. Analyzing the functional and anatomical outcomes of the closure techniques.
  5. Comparing patient satisfaction and quality of life measures.

详细描述

The choice of surgical technique for stabilizing ball implants following evisceration has a significant impact on both functional and aesthetic outcomes for patients. Evisceration, a procedure that involves the removal of intraocular contents while preserving the scleral shell and extraocular muscles, is typically performed to alleviate pain in a blind eye, prevent sympathetic ophthalmia, or improve the cosmetic appearance of a disfigured eye (Shields et al. 2022). Ball implants are commonly used to restore the anatomic integrity and appearance of the orbit post-evisceration, but their success largely depends on the stability provided by the surgical technique employed (Wang et al. 2023).

Recent advancements in oculoplastic surgery have introduced several techniques to enhance implant stability, with the double flap and quadruple flap methods gaining particular attention. The double flap technique involves the use of two scleral flaps to secure the implant, while the quadruple flap method utilizes four flaps to provide greater coverage and stability (Singh et al. 2023). Despite the increasing popularity of these techniques, there remains a lack of consensus regarding their relative efficacy in ensuring implant stability and minimizing complications, such as migration, exposure, or extrusion of the implant (Patel et al. 2023).

Some studies suggest that the quadruple flap technique offers superior stability due to increased tissue coverage, potentially reducing the risk of postoperative complications (Gonzalez et al. 2024). However, other research indicates that the double flap technique is equally effective, with the added benefit of reduced operative time and fewer intraoperative adjustments (Harrison et al. 2023). Given these conflicting findings, there is a clear need for further investigation to determine the most effective approach for stabilizing ball implants post-evisceration.

This study aims to evaluate and compare the efficacy of the double flap and quadruple flap techniques in stabilizing ball implants following evisceration.

Patients and Methods This prospective, randomized, controlled trial was conducted at the Department of Ophthalmic Surgery, Faculty of Medicine, Fayoum University during the period from January 2024 to July 2024. Approval was granted by the institutional ethics committee, adhered to the tenets of the Declaration of Helsinki and informed consent was secured from all participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • Diagnosed with conditions necessitating evisceration with implant
  • Able to provide informed consent

排除标准

  • Previous ocular surgery affecting orbital anatomy
  • Systemic conditions influencing wound healing (e.g., diabetes, autoimmune disorders)
  • Allergy to implant materials

结局指标

主要结局

Evaluating the post-operative extrusion rates of the ball implant from the scleral shell

时间窗: Through study completion, an average of 6 months

The primary outcome measure was implant stability, assessed clinically and through imaging at 1, 3, and 6 months postoperatively to review any signs of implant migration or extrusion as well as signs of conjunctival erosion.

次要结局

  • Postoperative pain(From enrollment to the end of the follow up period after 6 months)
  • Postoperative complications(From enrollment to the end of the follow up period after 6 months)
  • Patient satisfaction with implant motility(From enrollment to the end of the follow up period after 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Kotb Abdallah

Lecturer of ophthalmology fayoum university

Fayoum University Hospital

研究点 (1)

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